Hangzhou AllTest Biotech Co.,Ltd

FDA Device Registration & Listing · Hangzhou Zhejiang, CN · Registration 3043127647

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3043127647
FEI Number
3043127647
Entity Name
Hangzhou AllTest Biotech Co.,Ltd
City/State/Country
Hangzhou Zhejiang, CN
Establishment Address
No.616 Dongwei Road, Qiantang District, Hangzhou Zhejiang 311222, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Hangzhou AllTest Biotech Co.,Ltd (Owner Number: 10050156)
Owner / Operator Contact Address
#383, Qiaoxin Road, Xiasha Street, Qiantang District, Hangzhou, CN-ZJ 310018, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Citest Multi-Drug Urine Cup Rapid Response Drug Screen Cup Atida Multiplex Drug of Abuse Urine Cup Test AllTest Multi-Drug Rapid Urine Test Cup CLIAwaived,Inc. Rapid Test Cup “RTC” + Fentanyl Premier Bio-Cup X ACRO Multi-Drug Rapid Test Cup AllTest Multi-Drug Urine Test Cup DrugTect Multi-Drug Rapid Urine Test Cup Discover Plus Multi-Drug Rapid Urine Test Cup Citest Multi-Drug Urine Test Cup ACRO Multi-Drug Rapid Urine Test Cup Atida Multiplex Drug of Abuse Rapid Urine Cup Test Cocaine(COC) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT Identify Diagnostics Multi-Drug Test Cup AllTest Multi-Drug Test Cup Citest Multi-Drug Urine Rapid Test Cup Identify Diagnostics Multi-Drug Rapid Test Cup SafeCup lll Multi-Drug Test Cup Labb Multi Drug Test Cup Identify Health Multi-Drug Rapid Test Cup QuickScreen At Home 18 Panel Drug Test with Fentanyl DrugTect Multi-Drug Rapid Test Cup DrugTect Multi-Drug Test Cup AllTest Multi-Drug Rapid Test Cup CLIAwaived, Inc. Rapid Test Cup Citest Multi-Drug Test Cup PRECISION PLUS Multi-Drug Test Cup Atida Multiplex Drug of Abuse Test Cup CERTUM Multi-Drug Test Cup CLIAwaived, Inc. Multi-Drug Rapid Test Cup Atida Multiplex Drug of Abuse Cup Test ACRO Rapid drug Screen Cup ACRO Rapid drug Screen Cup for Home use Identify Health Multi-Drug Test Cup CHOSEN Multi-Drug Test Cup Exploro Urine Drug Test Cup Rapid Response Multi-Drug Screen Cup Discover Multi-Drug Test Cup Labb Multi Drug Rapid Test Cup CHOSEN Multi-Drug Rapid Test Cup Berkeley health Multi-Drug Rapid Test CHOSEN Multi-Drug Urine Test Cup Atida Multiplex Drug of Abuse Rapid Urine Cup Test ACRO Multi-Drug Screen Cup Identify Health Multi-Drug Rapid Urine Test Cup Citest Multi-Drug Urine Test Cup AllTest Multi-Drug Rapid Urine Test Cup Identify Diagnostics Multi-Drug Urine Test Cup CHOSEN Multi-Drug Rapid Urine Test Cup Atida Multiplex Drug of Abuse Urine Cup Test ACRO Multi-Drug Screen Cup for Home use DrugTect Multi-Drug Rapid Urine Test Cup Identify Health Multi-Drug Urine Test Cup CLIAwaived,Inc. Complete Drug Test Cup “CDTC” Labb Multi Drug Urine Test Cup Labb Multi Drug Rapid Urine Test Cup DrugTect Multi-Drug Urine Test Cup ONESCREEN PLUS Multi-Panel Drug Test Cup AllTest Multi-Drug Urine Test Cup Identify Diagnostics Multi-Drug Rapid Urine Test Cup Citest Multi-Drug Urine Cup AllTest Fentanyl Rapid Test (Urine) Discover Fentanyl Rapid Test Cassette Rx Fentanyl Test (Urine) Rapid Response Fentanyl Test Cassette (Urine) Atida Fentanyl Drug of Abuse Test Rx CHOSEN Fentanyl Urine Rapid Test Cassette Rx Identify Health Digital Early Pregnancy Test Shinetell Plus Digital Early Pregnancy Test Citest Digital Early Pregnancy Home Test QuickScreen At Home Digital Early Pregnancy Test Atida Digital Early Pregnancy Test 2San Digital Early Pregnancy Test Optilyte Plus Digital Early Pregnancy Rapid Test Discover Fentanyl Rapid Test Cassette Atida Fentanyl Drug of Abuse Test Identify Health Fentanyl Urine Test Cassette McKesson Consult Fentanyl Urine Test Cassette Atida Fentanyl Test One Step Fentanyl Urine Test Cassette CHOSEN Fentanyl Rapid Urine Test Cassette Rapid Response Fentanyl Test Cassette CHOSEN Fentanyl Urine Rapid Test Cassette Mobilab Fentanyl Urine Test Cassette GenaCheck Fentanyl Urine Test Cassette Citest Fentanyl Home Test ACRO Fentanyl Urine Test Cassette DrugTect Fentanyl Urine Cassette RapiSure Fentanyl Urine Test Cassette ACRO Fentanyl Urine Test AllTest FentanyI Urine Test Cassette (Home Test) Rapid Response At-Home Fentanyl Test Cassette GenaCheck Fentanyl Urine Home-Use Test Cassette CLIAwaived, Inc. Rapid Drug Test Device“RDTD”for Fentanyl in Urine AimScreen Fentanyl Test 2SAN Fentanyl Urine Test Cassette RapiSure FYL Fentanyl Urine Test Cassette Identify Diagnostics Fentanyl Urine Cassette Citest Fentanyl Rapid Test Optilyte Digital Pregnancy Rapid Test Identify Health Digital Pregnancy Test Citest Digital Pregnancy Home Test CHOSEN Digital hCG Pregnancy Urine Rapid Test Midstream Atida Digital Pregnancy Test Rapid Response Digital Pregnancy Test Discover Digital Pregnancy Test Shinetell™ Digital Pregnancy Test CHOSEN hCG Early Pregnancy Urine Rapid Test Midstream ACRO Early Pregnancy Rapid Test ACESO Early Pregnancy Test Atida Early Pregnancy Test 2San Early Result Pregnancy Test Berkeley health hCG Early Pregnancy Rapid Test Citest Early Pregnancy Home Test ALLTEST hCG Early Pregnancy Rapid Test getTested Early Pregnancy Test One Step hCG Early Rapid Pregnancy Test Midstream Identify Health hCG Early Pregnancy Rapid Test THYROCHEK Thyroid Test Rapid TSH Cassette (Whole Blood) CLIAwaived Inc. Thyroid Test Rapid TSH Cassette (Whole Blood) AMPHETAMINE(AMP) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT Benzodiazepines(BZO) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT Opiates(OPI) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT Atida Viral Transport Medium Citest Viral Transport Medium ACRO Viral Transport Medium AllTest Viral Transport Medium Methadone(MTD) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT Methamphetamine(MET) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT Drink Check Test AllTest Urinary Tract Infection Test Atida Urinary Tract Infection Test Urinary Tract Infection Test Identify Health Urinary Tract Infection Test Rapid Response Urinary Tract infection Screen Strips Berkeley health Urinary Tract Infections Rapid Test 2San UTI Test Mobilab Urinary Tract Infection Test Vivoo At-Home UTI Test Strips Citest Urinary Tract Infection Test ACRO Urinary Tract Infection Rapid Test QuickScreen At Home Urinary Tract Infection Test Alltest Pregnancy Rapid Combo Test Cassette Citest hCG Pregnancy Combo Rapid Test Atida hCG Pregnancy Rapid Combo Test ACRO hCG Pregnancy Combo Test CLARITY hCG Combo Cassette Medline hCG Combo Pregnancy Test Cassette CHOSEN hCG Pregnancy Combo Rapid Test Cassette Rx Identify Health Pregnancy Rapid Combo Test Cassette Ovulation (LH) Rapid Test Cassette Ovulation (LH) Rapid Test Dipstick Digital LH Ovulation Test Strip Ovulation (LH) Rapid Test Midstream BERKELEY HEALTH Ovulation LH Test QuickScreen At Home Digital Ovulation Test Marijuana(THC) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT QuickScreen Multi Drug Screening Test With "Timer" Barbiturate(BAR) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT BERKELEY HEALTH Vaginal pH Test Methaqualone(MQL) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT Propoxyphene(PPX) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NFV Test, Benzodiazepine, Over The Counter Clinical Toxicology Class 2 862.3170 2024-06-26
PTH Test, Barbiturate, Over The Counter Clinical Toxicology Class 2 862.3150 2024-06-26
NFY Test, Cocaine And Cocaine Metabolites, Over The Counter Clinical Toxicology Class 2 862.3250 2024-06-26
PTG Test, Methadone, Over The Counter Clinical Toxicology Class 2 862.3620 2024-06-26
NGM Test, Phencyclidine (Pcp), Over The Counter Unknown Class U N/A 2024-06-26
NFT Test, Amphetamine, Over The Counter Clinical Toxicology Class 2 862.3100 2024-06-26
NGG Test, Methamphetamine, Over The Counter Clinical Toxicology Class 2 862.3610 2024-06-26
QAW Test, Tricyclic Antidepressants, Over The Counter Clinical Toxicology Class 2 862.3910 2024-06-26
NFW Test, Cannabinoid, Over The Counter Clinical Toxicology Class 2 862.3870 2024-06-26
NGL Test, Opiates, Over The Counter Clinical Toxicology Class 2 862.3650 2024-06-26
PVA Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3250 2017-11-02
NGI Test, Morphine, Over The Counter Clinical Toxicology Class 2 862.3640 2025-03-11
QBF Test, Propoxyphene, Over The Counter Clinical Toxicology Class 2 862.3700 2025-03-11
NGM Test, Phencyclidine (Pcp), Over The Counter Unknown Class U N/A 2025-03-11
NFT Test, Amphetamine, Over The Counter Clinical Toxicology Class 2 862.3100 2025-03-11
PTH Test, Barbiturate, Over The Counter Clinical Toxicology Class 2 862.3150 2025-03-11
NFV Test, Benzodiazepine, Over The Counter Clinical Toxicology Class 2 862.3170 2025-03-11
PTG Test, Methadone, Over The Counter Clinical Toxicology Class 2 862.3620 2025-03-11
NFY Test, Cocaine And Cocaine Metabolites, Over The Counter Clinical Toxicology Class 2 862.3250 2025-03-11
NGL Test, Opiates, Over The Counter Clinical Toxicology Class 2 862.3650 2025-03-11
NGG Test, Methamphetamine, Over The Counter Clinical Toxicology Class 2 862.3610 2025-03-11
NFW Test, Cannabinoid, Over The Counter Clinical Toxicology Class 2 862.3870 2025-03-11
QAW Test, Tricyclic Antidepressants, Over The Counter Clinical Toxicology Class 2 862.3910 2025-03-11
NGG Test, Methamphetamine, Over The Counter Clinical Toxicology Class 2 862.3610 2025-04-16
NFT Test, Amphetamine, Over The Counter Clinical Toxicology Class 2 862.3100 2025-04-16
QAW Test, Tricyclic Antidepressants, Over The Counter Clinical Toxicology Class 2 862.3910 2025-04-16
PTH Test, Barbiturate, Over The Counter Clinical Toxicology Class 2 862.3150 2025-04-16
NGL Test, Opiates, Over The Counter Clinical Toxicology Class 2 862.3650 2025-04-16
NFV Test, Benzodiazepine, Over The Counter Clinical Toxicology Class 2 862.3170 2025-04-16
NFW Test, Cannabinoid, Over The Counter Clinical Toxicology Class 2 862.3870 2025-04-16
PTG Test, Methadone, Over The Counter Clinical Toxicology Class 2 862.3620 2025-04-16
QBF Test, Propoxyphene, Over The Counter Clinical Toxicology Class 2 862.3700 2025-04-16
NGM Test, Phencyclidine (Pcp), Over The Counter Unknown Class U N/A 2025-04-16
NFY Test, Cocaine And Cocaine Metabolites, Over The Counter Clinical Toxicology Class 2 862.3250 2025-04-16
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2023-08-02
LCX Kit, Test, Pregnancy, Hcg, Over The Counter Clinical Chemistry Class 2 862.1155 2025-07-21
NGL Test, Opiates, Over The Counter Clinical Toxicology Class 2 862.3650 2023-11-02
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2023-11-02
LCX Kit, Test, Pregnancy, Hcg, Over The Counter Clinical Chemistry Class 2 862.1155 2024-08-19
LCX Kit, Test, Pregnancy, Hcg, Over The Counter Clinical Chemistry Class 2 862.1155 2024-04-10
JLW Radioimmunoassay, Thyroid-Stimulating Hormone Clinical Chemistry Class 2 862.1690 2019-07-30
PUX Test, Amphetamine, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3100 2017-11-02
PUZ Test, Benzodiazepine, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3170 2017-11-02
PVH Test, Opiates, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3650 2017-10-30
JSM Culture Media, Non-Propagating Transport Microbiology Class 1 866.2390 2025-04-16
PVE Test, Methadone, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3620 2017-11-02
PVD Test, Methamphetamine, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3610 2017-11-02
LJX Test, Urine Leukocyte Hematology Class 1 864.7675 2025-11-21
JMT Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) Clinical Chemistry Class 1 862.1510 2025-11-21
JHI Visual, Pregnancy Hcg, Prescription Use Clinical Chemistry Class 2 862.1155 2022-02-18
NGE Test, Luteinizing Hormone (Lh), Over The Counter Clinical Chemistry Class 1 862.1485 2024-05-27
PVJ Test, Cannabinoid, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3870 2017-11-02
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2019-12-31
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2019-12-31
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2019-12-31
JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology Class 2 862.3170 2019-12-31
PUY Test, Barbiturate, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3150 2017-11-02
LNW Paper, Obstetric Ph Clinical Chemistry Class 1 862.1550 2026-04-10
PVF Test, Methaqualone, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3630 2017-11-02
PVI Test, Propoxyphene, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3700 2017-11-02

Official Correspondent

Rosa Wu

US Agent Details

Joseph Fan Business: ACESO LABORATORIES INC. Email: manuel@acrobiotech.com Phone: (909) 5415085

Related Public Records

Same Entity

Hangzhou AllTest Biotech Co.,Ltd
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3027519599 Hangzhou AllTest Biotech Co.,Ltd Hangzhou Zhejiang, CN
3012073813 Hangzhou AllTest Biotech Co.,Ltd Hangzhou Zhejiang, CN

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K252550 Guangzhou Wondfo Biotech Co., Ltd. SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx 2025-11-18
K202567 Guangzhou Wondfo Biotech Co., Ltd. Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx 2020-09-25
K260065 Guangzhou Wondfo Biotech Co., Ltd. SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx 2026-04-28
K182701 Guangzhou Wondfo Biotech Co., Ltd. Wondfo T-Cup Multi-Drug Urine Test Cup 2018-12-03
K241741 Guangzhou Wondfo Biotech Co., Ltd. SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fentanyl (FTY) Urine Test Cassette; SAFElife™ T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel 2024-07-16

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Z-0072-2017 Siemens Healthcare Diagnostics, Inc. 2
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043127647. Last updated year: 2026. Please use registration number 3043127647 when referencing this establishment in official correspondence.
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